Roche DataCare POC Software Recalled for Diagnostic Issue
Roche Molecular Systems is recalling 126 units of DataCare POC software due to a device-associated diagnostic issue.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically indicates a temporary or medically reversible adverse health consequence. As no specific injuries, illnesses, or critical failures are reported in the source text, and the issue is described generally as a 'software issue,' it fits the Moderate category for a precautionary or low-risk software defect.
Plain-English summary
Roche Molecular Systems, Inc. is recalling 126 units of DataCare POC, a device-associated diagnostic software system. The software provides data management functionality for managing point-of-care testing data. The recall was initiated because the company became aware of a device-associated diagnostic software issue.
The affected units were distributed nationwide. The source text does not specify the exact nature of the software defect, the date of the recall, or any reported injuries or illnesses associated with the use of the software.
Consumers and healthcare facilities should contact Roche Molecular Systems, Inc. for further instructions regarding the recall and potential replacement or repair of the software.
The recalled product
- Product
- DataCare POC is an information management system that provides data management functionality for managing point-of -care testing data.
- Manufacturer
- Roche Molecular Systems, Inc.
- Hazard
- Affected units
- 126
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Device-associated diagnostic software
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 10 recalled by Roche Molecular Systems, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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